2013 Maryland Code
HEALTH OCCUPATIONS
§ 11-404 - Administration of drugs, medicine, etc

§11-404.

(a) Unless certified under this section, a licensed optometrist may not administer a topical ocular diagnostic pharmaceutical agent to a patient.

(b) The Board shall certify a licensed optometrist as qualified to administer topical ocular diagnostic pharmaceutical agents if the licensed optometrist submits to the Board evidence satisfactory to the Board that the licensed optometrist:

(1) Meets the educational requirements that the Board establishes for certification of qualification to administer topical ocular diagnostic pharmaceutical agents; and

(2) Has within 7 years before certification completed a course in pharmacology that meets the requirements of subsection (c) of this section.

(c) The course in pharmacology required by subsection (b) of this section shall:

(1) Be of at least the length that the Board establishes but not less than 70 course hours;

(2) Place emphasis on:

(i) Topical application of ocular diagnostic pharmaceutical agents for the purpose of examining and analyzing ocular functions; and

(ii) Allergic reactions to ocular diagnostic pharmaceutical agents; and

(3) Be given by an institution that is:

(i) Accredited by a regional or professional accrediting organization that is recognized or approved by the United States Commissioner of Education; and

(ii) Approved by the Board.

(d) The Board shall revoke the certification of qualification to administer topical ocular diagnostic pharmaceutical agents of any licensed optometrist who does not annually take a course of study, approved by the Board, that relates to the use of those agents.

(e) Certification of qualification under this section authorizes the licensed optometrist who is certified under this section to administer a topical ocular diagnostic pharmaceutical agent to a patient for diagnostic purposes but not for purposes of treatment.

(f) Except as expressly authorized under this section for diagnostic purposes or under § 11-404.1 of this subtitle for therapeutic purposes, an optometrist may not administer drugs or medicine to any patient.

(g) The Department shall collect and report statistical information on the incidences of negative reactions to the administration by optometrists of topical ocular diagnostic pharmaceutical agents.

§ 11-404 - 1. Therapeutically certified optometrists -- Certification

(a) Conduct requiring certification. -- Unless certified under this section, a licensed optometrist may not administer or prescribe any therapeutic pharmaceutical agents or remove superficial foreign bodies from a human eye, adnexa, or lacrimal system.

(b) Requirements for certification. --

(1) Except as provided in paragraph (2) of this subsection, the Board shall certify a licensed optometrist as a therapeutically certified optometrist if the licensed optometrist submits to the Board evidence satisfactory to the Board that the licensed optometrist:

(i) Has successfully completed at least 110 hours of a therapeutic pharmaceutical agents course approved by the Board;

(ii) Has successfully passed a pharmacology examination relating to the treatment and management of ocular disease, which is prepared, administered, and graded by the National Board of Examiners in Optometry or any other nationally recognized optometric organization as approved by the Secretary;

(iii) Is currently certified by the Board to administer topical ocular diagnostic pharmaceutical agents under § 11-404 of this subtitle; and

(iv) Has successfully completed an 8-hour course in the management of topical steroids approved by the Board.

(2) (i) Except as provided in subparagraph (ii) of this paragraph, an optometrist who has graduated on or after July 1, 2005 from an accredited school of optometry recognized by the Board is not subject to the requirements of paragraph (1) of this subsection.

(ii) If an optometrist who has graduated on or after July 1, 2005 from an accredited school of optometry recognized by the Board is not certified under this section within 3 years of graduation, the optometrist shall successfully complete a therapeutic pharmaceutical agents course and successfully pass a pharmacology exam under paragraph (1) of this subsection before the Board may certify the optometrist.

§ 11-404 - 2. Therapeutically certified optometrists -- Referrals; administration of topical therapeutic and oral pharmaceutical agents; restrictions

(a) "Refer" defined. -- In this section, "refer" means that a therapeutically certified optometrist:

(1) Informs the patient that the patient should see an ophthalmologist and give the ophthalmologist an opportunity to physically examine the patient; and

(2) Refrains from rendering further treatment for the specific condition that is the basis for the referral until the patient has been physically examined by an ophthalmologist.

(b) Administration of topical therapeutic pharmaceutical agents. --

(1) A therapeutically certified optometrist may administer and prescribe topical therapeutic pharmaceutical agents limited to:

(i) Ocular antihistamines, decongestants, and combinations thereof;

(ii) Ocular antiallergy pharmaceutical agents;

(iii) Ocular antibiotics and combinations of ocular antibiotics, excluding specially formulated or fortified antibiotics;

(iv) Anti-inflammatory agents;

(v) Ocular lubricants and artificial tears;

(vi) Tropicamide;

(vii) Homatropine;

(viii) Nonprescription drugs that are commercially available; and

(ix) Primary open-angle glaucoma medications, in accordance with subsection (c) of this section.

(2) Except as provided in paragraph (4) of this subsection, if a therapeutically certified optometrist administers or prescribes a topical therapeutic pharmaceutical agent listed in paragraph (1)(i) through (vii) of this subsection, and the patient does not have the expected response within 72 hours:

(i) The therapeutically certified optometrist shall consult with an ophthalmologist; and

(ii) The ophthalmologist may determine that the ophthalmologist needs to physically examine the patient.

(3) Except as provided in paragraph (4) of this subsection, if a therapeutically certified optometrist administers or prescribes a topical therapeutic pharmaceutical agent under paragraph (2) of this subsection, the therapeutically certified optometrist shall communicate with the patient to determine the response of the patient to the therapeutic pharmaceutical agent as soon as practicable after 72 hours of the time the agent was administered or prescribed.

(4) A therapeutically certified optometrist may administer or prescribe topical steroids in accordance with a practice protocol established by the Board.

(5) A therapeutically certified optometrist may not administer or prescribe:

(i) Antiviral agents;

(ii) Antifungal agents;

(iii) Antimetabolite agents; or

(iv) Antiparasitic agents.

(6) A therapeutically certified optometrist may dispense a topical therapeutic pharmaceutical agent listed in paragraph (1) of this subsection only if:

(i) No charge is imposed for the therapeutic pharmaceutical agent or for dispensing the agent; and

(ii) The amount dispensed does not exceed a 72-hour supply, except that if the minimum available quantity for dispensing is greater than a 72-hour supply, the minimum available quantity may be dispensed.

(c) Administration of agents for glaucoma. --

(1) A therapeutically certified optometrist may administer and prescribe topical therapeutic pharmaceutical agents for glaucoma only:

(i) For patients with primary open-angle glaucoma;

(ii) After the optometrist refers the patient to an ophthalmologist; and

(iii) After the ophthalmologist and optometrist jointly and promptly develop a written individualized treatment plan that is signed by the ophthalmologist and optometrist and includes:

1. All tests and examinations that led to the diagnosis;

2. An initial schedule of all tests and examinations necessary to treat the patient's condition;

3. A medication plan;

4. A target intraocular pressure; and

5. Criteria for surgical intervention by the ophthalmologist.

(2) (i) A treatment plan developed under this subsection may be modified only after both the optometrist and the ophthalmologist consult together and consent to the modification.

(ii) Each modification shall be noted in the optometric record of the patient.

(3) A therapeutically certified optometrist who treats a patient with primary open-angle glaucoma in accordance with this section:

(i) Shall refer the patient to an ophthalmologist at least once a year after the initial mandatory referral under paragraph (1) of this subsection;

(ii) May continue to render treatment under the joint treatment plan until the patient is examined by an ophthalmologist;

(iii) Shall consult with an ophthalmologist if:

1. The patient does not have the expected response to treatment;

2. The target intraocular pressure is not reached; or

3. There is worsening in a patient's visual field or optic nerve head; and

(iv) May perform and evaluate visual field tests, nerve fiber layer photos, and optic disc photos. The tests or photos shall be provided to an ophthalmologist for review by the ophthalmologist.

(d) Administration of oral pharmaceutical agents. --

(1) Except as provided in paragraphs (2) and (3) of this subsection, a therapeutically certified optometrist may not administer or prescribe any oral pharmaceutical agent for any purpose.

(2) (i) A therapeutically certified optometrist may administer and prescribe oral tetracycline and its derivatives only for the diagnosis and treatment of meibomitis and seborrheic blepharitis.

(ii) If a therapeutically certified optometrist administers or prescribes oral tetracycline or its derivatives to a patient in accordance with subparagraph (i) of this paragraph and the patient does not improve within 3 weeks of treatment, the optometrist shall refer the patient to an ophthalmologist.

(3) A therapeutically certified optometrist may administer or prescribe nonprescription drugs that are commercially available.

(e) Eyelid procedures generally prohibited. --

(1) Except as provided in paragraph (2) of this subsection, a therapeutically certified optometrist may not perform any procedure on the eyelid of a patient.

(2) A therapeutically certified optometrist may epilate with forceps an eyelash from the eyelid, adnexa, or lacrimal system of a patient.

(f) Removal of foreign bodies. -- A therapeutically certified optometrist may remove superficial foreign bodies from the human eye only if:

(1) The foreign body may be removed with a cotton-tipped applicator or blunt spatula; and

(2) The foreign body has not penetrated beyond the bowman's membrane of the cornea and is not within 2.5 millimeters of the visual axis.

(g) Orders for laboratory tests generally prohibited. --

(1) Except as provided in paragraph (2) of this subsection, a therapeutically certified optometrist may not order laboratory tests for a patient.

(2) A therapeutically certified optometrist may order a conjunctival culture.

(h) Child under age of 1 year. -- A therapeutically certified optometrist may not provide any therapeutic treatment listed in this section for a child under the age of 1 year.

(i) Referrals. -- Unless the standard of care requires an earlier referral, if a therapeutically certified optometrist diagnoses a corneal ulcer or infiltrate, and the patient does not have the expected response within 48 hours, the optometrist immediately shall refer the patient to an ophthalmologist.

(j) Standard of care. -- A therapeutically certified optometrist shall be held to the same standard of care as an ophthalmologist who is licensed under Title 14 of this article and who is providing similar services.

§ 11-404 - 3. Therapeutically certified optometrists -- Quality assurance

(a) Guideline recommendations. -- The Maryland Optometric Association and the Maryland Society of Eye Physicians and Surgeons shall recommend to the Secretary quality assurance guidelines for therapeutically certified optometrists and optometric care.

(b) Regulations establishing quality assurance program. --

(1) After considering the recommendations of the Maryland Optometric Association and the Maryland Society of Eye Physicians and Surgeons, the Secretary shall adopt regulations that establish:

(i) Standards of quality for therapeutically certified optometrists and optometric care;

(ii) An ongoing quality assurance program that includes the monitoring and study of the joint management of primary open-angle glaucoma patients under § 11-404.2 (c) of this subtitle;

(iii) A program to evaluate the cost of optometric care; and

(iv) A plan to monitor complaint investigation.

(2) The regulations shall require the Board to:

(i) Conduct a continuing study and investigation of therapeutically certified optometrists to ensure the quality of care they provide; and

(ii) Report to the Secretary, as the Secretary requires, on the results of the Board's study and investigation.

(3) The Board's study and investigation shall include:

(i) A peer review program; and

(ii) A review of patient optometric records that includes the collection and evaluation of data on the drugs being prescribed and administered and the appropriateness of treatment by therapeutically certified optometrists.

§ 11-404 - 4. Contact lenses

(a) In general. --

(1) In this section the following words have the meanings indicated.

(2) "Replacement contact lens prescription" means a prescription prepared by a licensed optometrist containing the information specified in this section and written expressly for the purpose of providing lenses which have already been properly fitted.

(3) "Immediate follow-up care" is that period of contact lens fitting time required to reach a contact lens prescription that is appropriate to the documented clinical needs of the patient.

(b) Contact lens prescriptions. -- A licensed optometrist shall ensure that each replacement contact lens prescription that the licensed optometrist prescribes for contact lenses:

(1) Contains all the information necessary for the replacement contact lens prescription to be properly dispensed, including but not limited to the:

(i) Lens manufacturer;

(ii) Type of lens;

(iii) Power of the lens, including plano or zero-powered contact lenses;

(iv) Base curve;

(v) Lens size;

(vi) Name of the patient;

(vii) Date the prescription was given to the patient;

(viii) Name and office location of the licensed optometrist who writes the replacement contact lens prescription; and

(ix) Expiration date of the replacement contact lens prescription; and

(2) Is reduced to writing and placed in the patient's permanent file.

(c) Replacement prescriptions. --

(1) (i) After a licensed optometrist releases the patient from immediate follow-up care, the patient may request the replacement contact lens prescription from the licensed optometrist.

(ii) If, after examination, the patient's prescription has not changed since the last examination, a licensed optometrist shall comply with the provisions of paragraph (2) of this subsection without requiring the patient to purchase contact lenses or to undergo immediate follow-up care.

(2) (i) Upon the request of a patient of a licensed optometrist, and without cost to the patient, the licensed optometrist shall provide the patient's replacement contact lens prescription to the patient or the patient's designee.

(ii) In responding to a request under paragraph (1) (i) of this subsection, a licensed optometrist shall transmit the contact lens prescription by mail, telephone, facsimile, e-mail, or any other means of communication that will, under normal circumstances, result in the designee receiving the information within 7 business days after the patient's request.

(iii) The replacement contact lens prescription that the licensed optometrist provides the patient under subparagraph (i) of this paragraph:

1. Shall contain the information necessary for the proper duplication of the current prescription of the patient;

2. Shall contain, subject to the provisions of subsection (d) of this section, an expiration date for the replacement contact lens prescription of not more than 24 months from the time the patient was first examined; and

3. May contain wearing guidelines or specific instructions for use of the contact lenses by the patient, or both.

(d) Expiration dates. -- The licensed optometrist shall enter into the patient's medical record the valid clinical reasons for a shorter expiration date and shall provide the patient with a written and oral explanation of the clinical reasons for a shorter expiration date.

(e) Liability. -- When a patient's prescription is dispensed by a person other than the licensed optometrist or a person associated directly or indirectly with the licensed optometrist, the licensed optometrist is not liable for any injury to or condition of a patient caused solely by the negligence of the dispenser.

(f) Improper contact lenses. -- A licensed optometrist who releases a replacement contact lens prescription to a patient may provide the patient with a written statement that wearing improperly fitted contact lenses may cause harm to the patient's eyes and that the patient should have an eye examination if there are any changes in the patient's vision, including pain or vision loss.

(g) Maintaining records. --

(1) A licensed optometrist who fills or provides a contact lens prescription shall maintain a record of that prescription in accordance with § 4-403 of the Health - General Article.

(2) A person other than a licensed optometrist who fills a contact lens prescription shall maintain a record of that prescription for 5 years.

(h) Civil fine. -- The Board may impose a civil fine of no more than $ 1,000 on a licensed optometrist who fails to provide a replacement contact lens prescription or who knowingly dispenses contact lenses without a valid and unexpired replacement contact lens prescription, or who otherwise fails to comply with this title.